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Completed

NCT Number: NCT03852446

Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers

This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07407, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smoker for at least 3 months
  • BMI within 18 to 30 kg/m2
  • Able to speak, read, and understand English or Spanish

Exclusion criteria

  • Clinically significant cardiac, pulmonary, hepatic or renal disease
  • History of substance abuse or alcohol dependence within past 2 years
  • Inability to fast for a minimum of 14 hours
  • Inability to swallow large capsules/tablets
  • Pending legal charges or is on probation

Treatment and study plan

Indoximod HCL (F2) tablets

Drug

The doses will be ascending per cohort from 600 mg to 2400 mg

Indoximod base formulation

Drug

Single oral administration of 1200 mg

Placebo

Other

The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve

    Time frame: up to 20 Days

    Part 2

  2. Pharmacokinetics: Serum concentrations (Cmax/Steady State)

    Time frame: up to 20 Days

    Part 2

  3. Pharmacokinetics: Serum concentrations (Cmax/Steady State)

    Time frame: up to 4 Days

    Part 1

Secondary outcomes

  1. Percentage of patients with adverse events

    Time frame: up to 18 Days

    Part 1

  2. Percentage of patients with adverse events

    Time frame: up to 36 Days

    Part 2

Sponsors and collaborators

Lead sponsor

NewLink Genetics Corporation

Industry

Registry information

Official study title

A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers

Acronym: NLG2111

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 25, 2019
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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